METHYLENE BLUE- methylene blue injection 
Zydus Lifesciences Limited

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Methylene Blue Injection, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1768-1

Methylene Blue Injection, USP

50 mg/10 mL (5 mg/mL)

Intravenous use only

Single-Dose vial

Rx only

50 mg per 10 mL vial

NDC 70771-1768-5

Methylene Blue Injection, USP

50 mg/10 mL (5 mg/mL)

Intravenous use only

5 X 10 mL Single-Dose Vial

Rx only

50 mg per 10 mL carton

NDC 70771-1767-1

Methylene Blue Injection, USP

10 mg/2 mL (5 mg/mL)

Intravenous use only

Single-Dose vial

Rx only

image

NDC 70771-1767-5

Methylene Blue Injection, USP

10 mg/2 mL (5 mg/mL)

Intravenous use only

5 X 2 mL Single-Dose Vial

Rx only

10 mg per 2 mL carton
METHYLENE BLUE 
methylene blue injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1767
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH) METHYLENE BLUE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1767-55 in 1 CARTON12/05/2023
1NDC:70771-1767-12 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21563612/05/2023
METHYLENE BLUE 
methylene blue injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1768
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH) METHYLENE BLUE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1768-55 in 1 CARTON12/05/2023
1NDC:70771-1768-110 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21563612/05/2023
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(70771-1767, 70771-1768) , ANALYSIS(70771-1767, 70771-1768)

Revised: 4/2024
Document Id: 038526e4-f39d-4a7a-823d-a7ee7f3a0ed5
Set id: df3568d6-d509-4c93-9a92-0e3d1d8514dc
Version: 2
Effective Time: 20240424
 
Zydus Lifesciences Limited